Diagnostic Kit Developed from Intact HCV Virus

The antigen for producing a hepatitis C virus (HCV) diagnostic kit was purified directly from the intact HCV virus particles instead of using recombinant HCV proteins or synthesized polypeptides as with other HCV diagnostics currently on the market.

Intact HCV virus antigens have better epitopes, which could be more specifically recognized by the HCV antibody. This new generation of enzyme-linked immunosorbant assay (ELISA) diagnostic kits for HCV antibody detection dramatically improves the accuracy of the HCV diagnostics, and significantly advances the diagnostic window of HCV infection.

Chinese Food and Drug Administration (FDA) Regulation approval has been given to the new HCV diagnostic kit, which is a product of Worldwide Biotech and Pharmaceutical Co. (Yangling Daiying, WWBP, Xi'an, China; www.worldwidebio.com). The kit is the first product from the company's HCV research pipeline to be released on the market. The project was also awarded Outstanding Project Derived from Chinese Patent by the Chinese state government.

This transition is a critical milestone of our growth strategy to become the leading figure in the research & development of HCV diagnostics and therapeutics, said Wenxia Guo, CEO and president of WWBP, Our ability to release a highly sensitive and accurate HCV diagnostic product based on the intact HCV virus, that we cultured, strongly enhances the leading position of our company in HCV research.



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